search
Back to results

Mepolizumab for Eosinophilic Fasciitis

Primary Purpose

Eosinophilic Fasciitis

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Mepolizumab
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilic Fasciitis focused on measuring Mepolizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female patients 18 years or older.
  • History and physical examination consistent with EF
  • Full thickness skin biopsy characteristic of eosinophilic fascitis and/or MRI radiographic findings characteristic of EF
  • Documented peripheral eosinophilia (≥500 microliter)
  • Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
  • Patients who read and sign an approved informed consent for this study

Exclusion Criteria:

  • Eosinophilic fascitis disease duration > 5 years
  • Known history of adverse reaction to mepolizumab (Nucala)
  • Pregnant females
  • Females actively trying to conceive
  • Vulnerable study population
  • Asthma requiring inhaled cortiosteroids

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single Arm

    Arm Description

    Patients with a biopsy proven diagnosis of eosinophilic fasciitis

    Outcomes

    Primary Outcome Measures

    Modified Rodnan Skin Score (mRSS)
    Mean change before and after treatment. The mRSS is a standardized scored assessment of tissue sclerosis as assessed by palpitation.

    Secondary Outcome Measures

    Localized Scleroderma Skin Severity Index (mLoSSI) score
    Mean change before and after treatment. mLoSSI score quantifies disease activity.
    Localized Scleroderma Damage Index (LoSDI) score.
    Mean change before and after treatment. LoSDI score quantifies disease damage.
    Localized Scleroderma Cutaneous Assessment Tool (LoSCAT)
    Mean change before and after treatment. LoSCAT is a composite score of disease activity (mLoSSI) and disease damage (LoSDI).
    Physician's Global Assessment of Disease Activity (PhysGA-A)
    Mean change before and after treatment. PhysGA-A is a 100-mm analog scale anchored by "inactive" at 0 and "markedly active" at 100.
    Physician's Global Assessment of Disease Damage (PhysGA-D)
    Mean change before and after treatment. PhysGA-D is a 100-mm analog scale anchored by "no damage" at 0 and "markedly damaged" at 100.
    Dermatology Quality of Life Index (DLQI)
    Mean change before and after treatment. DLQI is a skin-specific health questionnaire with higher scores reflecting decreased quality of life
    Patient Global Assessment of Disease Severity (PtGA-S)
    Mean change before and after treatment.PhysGA-A is a 100-mm analog scale anchored by "not severe" at 0 and "very severe" at 100.

    Full Information

    First Posted
    March 10, 2020
    Last Updated
    February 13, 2023
    Sponsor
    Mayo Clinic
    Collaborators
    GlaxoSmithKline
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04305678
    Brief Title
    Mepolizumab for Eosinophilic Fasciitis
    Official Title
    Mepolizumab for the Treatment of Eosinophilic Fasciitis; An Open-Label, Single-Arm, Exploration Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Funding lost from Sponsor.
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mayo Clinic
    Collaborators
    GlaxoSmithKline

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a proof of concept pilot study to investigate the efficacy of mepolizumab in the treatment of eosinophilic fasciitis.
    Detailed Description
    This is an exploratory study designed to generate preliminary data in evaluating the efficacy of mepolizumab (Nucala) in the treatment of EF using mean change in the Rodnan Skin score (mRSS) before and after treatment. The study is powered at 90% to detect a 4 point change in the mRSS at a 5% significant level with a minimum target accrual of 6 patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Eosinophilic Fasciitis
    Keywords
    Mepolizumab

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Model Description
    Mepolizumab for the treatment of eosinophilic faciitis.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single Arm
    Arm Type
    Experimental
    Arm Description
    Patients with a biopsy proven diagnosis of eosinophilic fasciitis
    Intervention Type
    Drug
    Intervention Name(s)
    Mepolizumab
    Other Intervention Name(s)
    Nucala
    Intervention Description
    Mepolizumab (Nucala) 400 mg SC every 4 weeks x 24 weeks
    Primary Outcome Measure Information:
    Title
    Modified Rodnan Skin Score (mRSS)
    Description
    Mean change before and after treatment. The mRSS is a standardized scored assessment of tissue sclerosis as assessed by palpitation.
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    Localized Scleroderma Skin Severity Index (mLoSSI) score
    Description
    Mean change before and after treatment. mLoSSI score quantifies disease activity.
    Time Frame
    24 weeks
    Title
    Localized Scleroderma Damage Index (LoSDI) score.
    Description
    Mean change before and after treatment. LoSDI score quantifies disease damage.
    Time Frame
    24 weeks
    Title
    Localized Scleroderma Cutaneous Assessment Tool (LoSCAT)
    Description
    Mean change before and after treatment. LoSCAT is a composite score of disease activity (mLoSSI) and disease damage (LoSDI).
    Time Frame
    24 weeks
    Title
    Physician's Global Assessment of Disease Activity (PhysGA-A)
    Description
    Mean change before and after treatment. PhysGA-A is a 100-mm analog scale anchored by "inactive" at 0 and "markedly active" at 100.
    Time Frame
    24 weeks
    Title
    Physician's Global Assessment of Disease Damage (PhysGA-D)
    Description
    Mean change before and after treatment. PhysGA-D is a 100-mm analog scale anchored by "no damage" at 0 and "markedly damaged" at 100.
    Time Frame
    24 weeks.
    Title
    Dermatology Quality of Life Index (DLQI)
    Description
    Mean change before and after treatment. DLQI is a skin-specific health questionnaire with higher scores reflecting decreased quality of life
    Time Frame
    24 weeks.
    Title
    Patient Global Assessment of Disease Severity (PtGA-S)
    Description
    Mean change before and after treatment.PhysGA-A is a 100-mm analog scale anchored by "not severe" at 0 and "very severe" at 100.
    Time Frame
    24 weeks.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male and female patients 18 years or older. History and physical examination consistent with EF Full thickness skin biopsy characteristic of eosinophilic fascitis and/or MRI radiographic findings characteristic of EF Documented peripheral eosinophilia (≥500 microliter) Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and Patients who read and sign an approved informed consent for this study Exclusion Criteria: Eosinophilic fascitis disease duration > 5 years Known history of adverse reaction to mepolizumab (Nucala) Pregnant females Females actively trying to conceive Vulnerable study population Asthma requiring inhaled cortiosteroids
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jason C Sluzevich, M.D.
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://www.mayo.edu/research/clinical-trials
    Description
    Mayo Clinic Clinical Trials

    Learn more about this trial

    Mepolizumab for Eosinophilic Fasciitis

    We'll reach out to this number within 24 hrs